Label: ESSENTIAL DEFENSE EVERYDAY CLEAR BROAD SPECTRUM SPF 47 SUNSCREEN- zinc oxide and octinoxate lotion

  • NDC Code(s): 0023-5738-18, 0023-5738-25
  • Packager: Allergan, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 2, 2016

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  • Active ingredients

    Octinoxate 7.5%

    Zinc Oxide 12.0%

  • Purpose

    Sunscreen

    Sunscreen

  • Uses

    • Helps prevent sunburn
    • If used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun
  • Warnings

    For external use only

    Do not use on damaged or broken skin

    When using this product keep out of eyes. Rinse with water to remove. 

    Stop use and ask a doctor if skin rash occurs 

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply liberally 15 minutes before sun exposure
    • Use a water resistant sunscreen if swimming or sweating
    • Reapply at least every 2 hours
    • Sun Protection Measures Spending time in the sun increases the risk of skin cancer, premature skin aging and other skin damage. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including limiting time in the sun from 10 a.m.-2 p.m., and wearing protective clothing
    • Children under 6 months: Ask a doctor
  • Inactive ingredients

    Water, Cyclopentasiloxane, Niacinamide, Oleth-3 Phosphate, Octyldodecyl Neopentanoate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glycerin, Camellia Sinensis Leaf Extract, Polygonum Aviculare Extract, Tocopheryl Acetate, Sodium Hyaluronate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Triethoxycaprylylsilane, Polyisobutene, PEG-7 Trimethylolpropane Coconut Ether, Butylene Glycol, Disodium EDTA, Sodium Hydroxide, Citric Acid, Caprylyl Glycol, Sorbic Acid, Phenoxyethanol, Ethylhexylglycerin

  • Other information

    • Protect this product from excessive heat and direct sun
    • Store at room temperature 15° - 30°C (59° - 86°F)
  • Questions or comments?

    www.skinmedica.com 

  • Principal Display Panel - Carton Label

    SkinMedica®
    ESSENTIAL
    DEFENSE
    EVERYDAY CLEAR™
    BROAD SPECTRUM
    SPF 47
    SUNSCREEN
    OILY &
    COMBINATION SKIN
    SUN PROTECTION
    Net Wt. 1.85 Oz. / 52.5 g

    SkinMedica® ESSENTIAL DEFENSE EVERYDAY CLEAR™ BROAD SPECTRUM SPF 47 SUNSCREEN OILY & COMBINATION SKIN SUN PROTECTION Net Wt. 1.85 Oz. / 52.5 g

  • Principal Display Panel - Tube Label

    SkinMedica®
    ESSENTIAL
    DEFENSE
    EVERYDAY CLEAR™
    BROAD SPECTRUM
    SPF 47
    SUNSCREEN
    OILY &
    COMBINATION SKIN
    SUN PROTECTION
    Net Wt. 1.85 Oz. / 52.5 g

    SkinMedica® ESSENTIAL DEFENSE EVERYDAY CLEAR™ BROAD SPECTRUM SPF 47 SUNSCREEN OILY & COMBINATION SKIN SUN PROTECTION Net Wt. 1.85 Oz. / 52.5 g

  • INGREDIENTS AND APPEARANCE
    ESSENTIAL DEFENSE EVERYDAY CLEAR BROAD SPECTRUM SPF 47 SUNSCREEN 
    zinc oxide and octinoxate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0023-5738
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) ZINC OXIDE120 mg  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
    POLYISOBUTYLENE (1300 MW) (UNII: 241BN7J12Y)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SORBIC ACID (UNII: X045WJ989B)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0023-5738-181 in 1 CARTON03/16/2016
    152.5 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0023-5738-256 in 1 CARTON03/16/2016
    27.1 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/16/2016
    Labeler - Allergan, Inc. (144796497)
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